Health Canada today suspended all medical device licences issued to and associated with IND Diagnostic of Delta, B.C., under its powers in the Food and Drugs Act, because of concerns about the company's management systems and distribution practices. The suspension means the devices can no longer be legally sold in Canada by any person. Health Canada's decision to suspend these licences is not based on an identified issue with the safety and effectiveness of any particular device.

The devices whose licences were suspended were sold directly by IND Diagnostic or by one of 13 private label manufacturers. The private label manufacturers are companies that purchased IND Diagnostic products and sold them under other names.

The devices include test kits used in pregnancy and ovulation, screening for blood in stool, urinary tract infections, infectious disease and illicit drugs. Some of the tests were sold in retail outlets, including discount/dollar stores for home use, while others were only sold for use by health professionals or laboratories.

In addition to the concerns about IND Diagnostic's management system for licenced devices, Health Canada found the company was importing unlicensed medical devices mainly for export to other countries. Health Canada is not aware of these unlicensed devices being distributed to the Canadian public or the health care system. When Health Canada discovered this situation, it notified its international health partners and the Canada Border Services Agency to help ensure the devices were no longer being imported. IND Diagnostic has voluntarily recalled these unlicensed devices.

The following chart lists the diagnostic tests (with their medical device license numbers) manufactured by IND Diagnostic or other private label manufacturers that had their licences suspended by Health Canada on Feb. 8, 2013. This suspension is immediate and means that the medical devices (the diagnostic tests listed below) included in these licences can no longer be legally sold in Canada by any person.

List of Diagnostic Tests from IND Diagnostic and Other Private Label Manufacturers Sold in Canada

Media enquiries

Health Canada
(613) 957-2983

Public enquiries

613-957-2991
1-866-225-0709

What Health Canada is doing

Health Canada is continuing to monitor this situation. If the Department is made aware of ongoing sales of products whose licences have been suspended, it will consider taking further action as warranted.